Clinical Trial Details


Research Study Summary

Effects of Enteral Glutamine Supplementation on Mortality and Infectious Morbidity in Severely Burned Patients: a Multi-center Pilot Trial

Enteral glutamine has been found to decrease mortality in critically ill patients and blood infection in trauma patients.
In our pilot study (Critical Care Medicine, 2003, 31:2444) we found the same protective effect of glutamine against blood infection in severely burned adult patients. In addition, a significant decrease in mortality was observed with glutamine. These results should be tested with a multi-center trial because our study was small and did not have mortality as an end point. Since such a large multi center study has never been conducted in burn patients, a pilot study that will test its feasibility seems warranted.
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CW ID: 222887
Date Last Changed: February 2, 2017

Clinical Trial Snapshot

Both Male and Female
18 and up
Overall Status
Lead Sponsor
Queen's University
Facility Type


Inclusion Criteria:
  1. Deep 2nd and/or 3rd degree burns requiring grafting
  2. a.) Patients 18 - 59 years of age without inhalation injury TBSA* = 20% b.) Patients 18 - 59 years of age with inhalation injury TBSA* = 15% c.) Patients = 60 years of age (with or without inhalation injury) TBSA* = 10%
*TBSA - Total Burn Surface Area

Exclusion Criteria:

  1. 72 hrs from admission to ICU to time of consent.
  2. Patients younger than 18 years of age
  3. In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 µmol/L or a urine output of less than 500 ml/last 24 hours (or 80 ml/last 4 hours if a 24 hour period of observation is not available). In patients with acute on chronic renal failure (pre-dialysis), an absolute increase of >80 µmol/L from baseline or pre-admission creatinine or a urine output of <500 ml/last 24 hours (or 80 ml/last 4 hours) will be required. Patients with chronic renal failure on dialysis will be excluded.
  4. Liver cirrhosis - Child's class C liver disease
  5. Pregnancy
  6. Absolute contra-indication for EN: intestinal occlusion or perforation, abdominal injury
  7. Patients with injuries from high voltage electrical shock
  8. Patients who are moribund
  9. Patients with extreme body sizes: BMI < 18 or > 50
  10. Enrolment in another industry sponsored ICU intervention study
  11. Received glutamine supplement for > 24 hrs prior to randomization
  12. Known allergy to maltodextrin, corn starch, corn, corn products or glutamine


Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 844-4133

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